CompletedNot Applicable

Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy

Austria, France2,248 participantsStarted 2021-03-25

Plain-language summary

The study aims to evaluate a modified antiplatelet therapy associated with Firehawk low-dose rapamycin DES in acute myocardial infarction patients treated with complete revascularization strategy. The modified antiplatelet therapy consists of a reduced duration of Dual Antiplatelet Therapy post procedure (ie. 1 month duration) followed by P2Y12 inhibitor monotherapy for the next 11 months. It is hypothesized that in the setting of clinically stable, low to moderate complexity acute Myocardial Infarction patients, a modern approach combining a stent with high biocompatibility feature, complete revascularization strategy and modified antiplatelet therapy may be associated with similar outcomes, or even a significant benefit compared with guidelines-recommended 12-month DAPT. This benefit could be driven by a reduced risk in significant bleeding events, while keeping a comparable protection against ischemic risk. Enrolled subjects will be randomized in a 1:1 ratio to either cessation of aspirin at 1 months, either continuation of DAPT. Selection of the P2Y12 inhibitor agent is left to investigator judgment but has to be in line with the current ESC guidelines. Subjects treated with the Firehawk or Firehawk Liberty coronary stent will be included in this study.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (General): * Troponin-positive Non-ST-Elevation MI, requiring early invasive treatment (PCI), or ST-Elevation MI requiring primary PCI, and PCI occurred within the last 7 days * Subject is eligible for per-protocol antiplatelet treatments * Written informed consent Inclusion Criteria (Procedural/angiographic): * Successful revascularization * All treated lesions: * In native coronary arteries only * In vessels with visual reference diameter ≥2.25 mm and ≤ 4.00 mm * Implanted with the study device * Maximum 3 lesions treated (\*) * Maximum total stent length ≤ 80 mm * Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 7 days from the index procedure. Exclusion Criteria (General): * Subjects with prior STEMI or prior PCI within 12 months before index admission * Prior Coronary Artery Bypass Graft (CABG) Surgery * Cardiogenic shock * Secondary PCI * Fibrinolysis * Prior stent thrombosis * Planned PCI, CABG, or surgery within 12 months * Need for Oral Anti-Coagulation therapy * Ischemic stroke or ICH within 12 months * eGFR \<30 mL/min/1.73 m2 or dialysis * Active bleeding at time of inclusion or high risk for major bleeding * History of bleeding diathesis or coagulopathy or subject refuse blood transfusions * Stage B or C liver cirrhosis or active cancer within 12 months * Baseline haemoglobin \<13 g/dL (12g/dL for women) or anaemia requiring transfusio…

What they're measuring

Net Adverse Clinical and Cerebral Events (NACCE)

Timeframe: 11 months post randomization

Trial details

NCT IDNCT04753749

SponsorMicroPort CRM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-05